A Study to Evaluate the Effect of Renal Impairment on the Pharmacokinetics of AL-335

Renal Insufficiency Clinical Trial

Official title:

An Open-label, Single-dose Study to Evaluate the Effect of Renal Impairment on the Single-dose Pharmacokinetics of AL-335

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02894905
• Other study ID #: CR108225
• Secondary ID: 64294178HPC1009
• Status: Completed
• Phase: Phase 1
• First received: September 6, 2016
• Last updated: December 18, 2017
• Start date: September 13, 2016
• Est. completion date: August 16, 2017

Study information

• Verified date: December 2017
• Source: Janssen Research & Development, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the pharmacokinetics (PK) of a single oral dose of AL-335 in participants with various degrees of impaired renal function (mild, moderate, and severe) compared to participants with normal renal function.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: August 16, 2017
• Est. primary completion date: August 8, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

Cohorts 1-4:

• Participant must have a body mass index (BMI; weight in kilogram (kg) divided by the square of height in meters) of 18 to 36 kilogram per meter square (kg/m^2), extremes included, and a body weight not less than 50.0 kg

• Participants must agree to follow all requirements that must be met during the study as noted in the Inclusion and Exclusion Criteria (eg, contraceptive requirements)

• Female participant must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for a period of 30 days after study drug administration

• Male participant must agree not to donate sperm from enrollment (Day 1) in the study until at least 30 days after receiving the study drug

Cohorts 1-3:

• Participant must have stable renal function

• Participant must be otherwise healthy except for the renal impairment and its underlying disease states and mild comorbidities and participant must be medically stable on the basis of physical examination, medical history, vital signs, 12-lead electrocardiogram (ECG), and clinical laboratory tests performed at screening

• Participants must have an estimated glomerular filtration rate (eGFR) less than (<) 90 milliLiter per minute per 1.73 meter square (mL/min/1.73m^2). Mild renal impairment (eGFR 60 to <90 mL/min/1.73m^2); moderate renal impairment (eGFR 30 to <60 mL/min/1.73m^2); severe renal impairment (eGFR <30 mL/min/1.73m^2 not requiring dialysis)

Cohort 4:

• Participant must be healthy on the basis of physical examination, medical history, vital signs, 12-lead ECG, and clinical laboratory tests performed at screening

• Participants must have an eGFR greater than or equal to (>=) 90 mL/min/1.73m^2

Exclusion Criteria:

Cohorts 1-4:

• Participant has a history of any illness (unrelated to renal impairment or its underlying disease, as appropriate) that, in the opinion of the investigator, might confound the results of the study or pose an additional risk in administering study drug to the participant. This may include but is not limited to history of relevant drug or food allergies, history of cardiovascular or central nervous system disease, history or presence of clinically significant pathology, chronic skin disease, or history of mental disease

• Participant who is on a vegetarian diet or who takes creatine supplements, and who has a non-standard muscle mass, example (eg), amputation, malnutrition, muscle wasting, or extremely muscular (body building)

• Participant has a history of hepatitis B surface antigen (HBsAg) or hepatitis C antibody (anti HCV) positive, or other clinically active liver disease, or tests positive for HBsAg or anti-HCV at screening

• Participant has a history of human immunodeficiency virus (HIV) antibody positive, or tests positive for HIV at screening

• Participant who smokes more than 10 cigarettes or 2 cigars or 2 pipes per day from within 3 months before screening until the end of the study

• Participant is a woman who is pregnant, or breast-feeding, or planning to become pregnant from signing of the Informed Consent Form (ICF) onwards until 30 days after study drug administration

• Participant is a man who plans to father a child while enrolled in this study (Day 1) until 30 days after study drug administration.

Cohorts 1-3:

• Participant requires dialysis

• Participant with imminent renal replacement therapy (ie, during the study period)

Related Conditions & MeSH terms

• Renal Insufficiency

Intervention

Drug:
• AL-335
Participants with various degrees of impaired renal function (mild [Cohort 1], moderate [Cohort 2], severe [Cohort 3]) and normal renal function (Cohort 4) will receive a single oral dose of AL-335 800 mg (given as 2*400-mg tablets).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Research & Development, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Observed Concentration (Cmax) of AL-335	The Cmax is the maximum observed concentration of analyte (AL-335).	Pre-dose, and at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 28, 32, 36, 48, 60, and 72 hours post-dose
Primary	Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)	The AUClast is the area under the analyte (AL-335) concentration-time curve from time zero (0) to time of the last quantifiable concentration.	Pre-dose, and at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 28, 32, 36, 48, 60, and 72 hours post-dose
Primary	Area Under the Concentration-Time Curve From Time Zero to Infinite Time (AUCinfinity)	The AUCinfinity is the area under the plasma concentration-time curve from time zero to infinite time, calculated as the sum of AUC(last) and C(last)/lambda(z); wherein AUC(last) is area under the plasma concentration-time curve from time zero to last quantifiable time, C(last) is the last observed quantifiable concentration, and lambda(z) is elimination rate constant.	Pre-dose, and at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 28, 32, 36, 48, 60, and 72 hours post-dose
Secondary	Number of Participants With Adverse Events as a Measure of Safety and Tolerability		Up to follow-up (Approximately 30-35 days after study drug administration)